A Phase III, Double-Blind, Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy

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Winston-Salem,
North Carolina27157

Purpose:

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective
in limiting weight loss caused by cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting
weight loss and improving quality of life in patients who have head and neck cancer and are
undergoing radiation therapy.

Study summary:

OBJECTIVES:
- Determine the effect of megestrol on the weight of patients with head and neck cancer
who are undergoing localized radiotherapy.
- Determine whether health-related quality of life improves in patients treated with
megestrol.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus
platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type
of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment
arms.
- Arm I: Patients receive oral megestrol daily beginning within the first three days of
radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after
completion of radiotherapy.
- Arm II: Patients receive oral placebo daily according to the schedule for megestrol in
arm I.
Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8,
12, and 16 weeks after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study
within 14 months.

Criteria:

DISEASE CHARACTERISTICS:
- Histologically proven resected or unresectable stage I-IV epithelial head and neck
cancer
- Must be scheduled to receive a total dose of radiotherapy of at least 5,000 cGy in
fraction sizes of no greater than 200 cGy
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No history of congestive heart failure or thromboembolic events
- No uncontrolled hypertension, active thromboembolic disease, or myocardial infarction
within the past 3 months
Pulmonary:
- No history of pulmonary edema
Other:
- No other malignancy within the past 3 years except curatively treated carcinoma in
situ of the cervix or nonmelanoma skin cancer
- No feeding tube
- No preexisting or uncontrolled diabetes with glycosylated hemoglobin greater than 10%
- No history of Cushing's syndrome
- No dietary restriction (salt, sugar, or lipid)
- No serious medical or psychiatric illness that would preclude study
- No significant ascites, pleural effusions, or edema that may inhibit oral food intake
or invalidate weight measurements
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed
Endocrine therapy:
- At least 1 year since prior corticosteroids, estrogens, progestins, or any other
steroid hormone
- No concurrent estrogens or other progestins
- Concurrent glucocorticoid replacement (10 mg of prednisone a day) allowed only if
patient experiences moderate "stress" (e.g., infection, trauma, or fluid loss
sufficient to require hospitalization and/or IV fluid replacement)
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the head and neck
Surgery:
- Not specified